Manufacturer
Acotec Scientific Co., Ltd.Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US)
Country / Region:China (CN)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K250688
- Device name
- Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US)
- Company
- Acotec Scientific Co., Ltd.
- Country / Region
- China(CN)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-03-06
- Decision date
- 2025-10-07
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- SurgeryOther
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
Cedar-T Endovenous Radiofrequency Catheters are intended for endovascular coagulation of blood vessels in patients with superficial vein reflux. The Endovenous Radiofrequency Generator is used with radiofrequency catheters intended for vessel coagulation.
Intended Use
Cedar-T Endovenous Radiofrequency Catheters are intended for endovascular coagulation of blood vessels in patients with superficial vein reflux. The Endovenous Radiofrequency Generator is used with radiofrequency catheters intended for vessel coagulation.
Device Description
y equivalent: Catheters: • Dimensions • Materials of Construction • DC Impedance • Shelf-Life Generator: • Indications for Use (predicate can be used with Stylet) • Feedback (works with Stylet) • Lifetime • Load (RF Catheters) Performance Data To demonstrate
Summary parsed at:2026-06-20 17:48:22 UTC